Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Caffeine 65 mg
Drx Choice Tablet, Film Coated
FDA Label NDC 68163-506
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc. for the product Drx Choice (NDC 68163-506). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purposes, uses, allergy alert: acetaminophen may cause severe skin reactions. symptoms may include:, liver warning:, caffeine warning:, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever
Pain reliever aid
Uses
- temporarily relieves minor aches and pain due to:
- headache
- muscular aches
Allergy Alert: Acetaminophen May Cause Severe Skin Reactions. Symptoms May Include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver Warning:
- This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Caffeine Warning:
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.
Do Not Use
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If
- you have liver disease
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- any new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
- children under 12 years: ask a doctor
Other Information
- store at room temperature
- close cap tightly after use
- read all product information before using.
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, D&C red no. 27, FD&C blue no. 2, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-866-467-2748
Principal Display Panel
Compare to Excedrin® Tension Headacheactive ingredients *
NDC 68163-506-15
DRx Choice
tension headache
relief
ASPIRIN-FREE
Acetaminophen 500 mg,Caffeine 65 mg
Pain Reliever / Pain Reliever Aid
ACTUAL SIZE
15 CAPLETS
TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.
IMPORTANT:Keep this carton for future reference on full labeling.
Distributed by: Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
*This product is not manufactured or distributed by Haleon CH Sarl., owner of the registered trademark Excedrin Tension Headache.
* Please review the disclaimer below.
